ISO-1 Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 397

Clinical Trials

Multiple clinical trials evaluate ISO-1 as a positron emission tomography radiotracer across various oncological and pulmonary conditions, including breast cancer, head and neck cancer, diffuse large B-cell lymphoma, and acute lung transplant rejection. Sponsored by prominent academic and research institutions such as Washington University School of Medicine, the University of Pennsylvania, and the National Heart, Lung, and Blood Institute, these Phase 1 and unassigned-phase studies encompass completed, active but non-recruiting, and terminated recruitment statuses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02284919	ACTIVE_NOT_RECRUITING	Breast Cancer; Breast Neoplasm	University of Pennsylvania	2015-03-11	PHASE1
NCT02284919	Active not recruiting	Breast Cancer\|Breast Neoplasm	University of Pennsylvania	2014-11	Phase 1
NCT02204202	Terminated	Lung Disease	Washington University School of Medicine\|National Heart Lung and Blood Institute (NHLBI)	2014-02	--
NCT00968656	COMPLETED	Breast Cancer; Head and Neck Cancer; Diffuse Large B-cell Lymphoma	Washington University School of Medicine	2009-01	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-01-09)

Check the ISO-1 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

ISO-1 selectively binds to macrophage migration inhibitory factor (MIF) to inhibit its D-dopachrome tautomerase activity with an IC50 of approximately 7 μM, thereby blocking downstream pro-inflammatory and pro-survival signaling cascades. This enzymatic blockade impairs cellular proliferation and tumor-associated inflammatory microenvironments, providing a clear biological rationale for its diagnostic and therapeutic investigation in malignancies such as breast cancer, head and neck cancer, and lymphoma.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).